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Female Libido Pill Considered by FDA Advisers

posted by martyb on Friday June 05 2015, @11:55AM   Printer-friendly
from the just-getting-started dept.

takyon writes:

A committee of advisers to the U.S. Food and Drug Administration (FDA) are meeting to consider whether the FDA should approve the first drug that aims to boost a woman's libido:

The FDA has twice before rejected the drug, called flibanserin, after previous advisory panels concluded there were questions about its safety and insufficient evidence that the drug was effective for women with low sex drives. Sprout Pharmaceuticals, which makes flibanserin, has submitted more research that the company hopes will finally convince the advisers and the agency the drug is ready for the market. The company's evidence includes a study it says shows women can safely drive after using the medication. One concern about the drug is that it can leave women drowsy the day after taking it, increasing the risks for accidents. "The review of flibanserin... represents a critical milestone for the millions of American women and couples who live with the distress of this life-impacting condition without a single approved medical treatment today," Cindy Whitehead, Sprout's CEO, said in a statement before the hearing began.

Flibanserin, which the company plans to sell under the brand name Addyi if approved, shifts the balance of three key brain chemicals, increasing dopamine and norepinephrine and decreasing serotonin.

The drug has long been the focus of an intense debate. The company and some advocacy groups, including the National Organization for Women and Even the Score, have suggested that the FDA is being sexist by holding the drug to a higher standard than drugs, such as Viagra and Cialis, for male sexual problems. The FDA denies those charges. In documents posted online in advance of the hearing, Hylton Joffe, director of the FDA's Division of Bone, Reproductive and Urologic Products, said that such claims "are misleading and inaccurate." "The FDA rejects claims of gender bias," Joffe wrote. "The FDA's regulatory decision for each product is based on an assessment of whether the benefits outweigh the risks, and does not take gender into consideration." Many women's health advocates agree with the agency's caution and remain opposed to the drug despite the company's new research.

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  • (Score: 4, Informative) by Gravis on Friday June 05 2015, @12:20PM

    by Gravis (4596) on Friday June 05 2015, @12:20PM (#192471)

    advocacy groups, including the National Organization for Women and Even the Score, have suggested that the FDA is being sexist by holding the drug to a higher standard than drugs, such as [REDACTED], for male sexual problems

    the difference here is what the drug actually does. in this case, it messes with neurotransmitters so it's more closely related to antidepressants and MDMA than it is to male impotence drugs which mess with the vascular system.

    Starting Score:    1  point
    Moderation   +2  
       Informative=2, Total=2
    Extra 'Informative' Modifier   0  
    Karma-Bonus Modifier   +1  
    Total Score:   4  

  • (Score: 2) by VLM on Friday June 05 2015, @12:47PM

    by VLM (445) on Friday June 05 2015, @12:47PM (#192479)

    in this case, it messes with neurotransmitters

    Its just refined paper currency ink, hows that work?

  • (Score: 3, Informative) by takyon on Friday June 05 2015, @12:55PM

    by takyon (881) <takyonNO@SPAMsoylentnews.org> on Friday June 05 2015, @12:55PM (#192485) Journal

    I asked about the filter (check the original submission link). The [REDACTED] is probably here to stay for now, because many dumb bots will use the unredacted words and generated thousands of comments at some point.

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    Certainly, the first drug for female sex drive may not be the most effective. Just because the idea was underfunded for decades doesn't mean Flibanserin/Addyi is a miracle. And there is big money involved in creating demand from thin air [sciencedaily.com]:

    Drug companies have not only sponsored the science of a new condition known as female sexual dysfunction, they have helped to construct it, in order to build global markets for new drugs, reveals an article in the British Medical Journal.

    Researching his new book 'Sex, Lies and Pharmaceuticals' Ray Moynihan, journalist and lecturer at the University of Newcastle in Australia, discovered that drug industry employees have worked with paid key opinion leaders to help develop the disease entity; they have run surveys to portray it as widespread; and they helped design diagnostic tools to persuade women that their sexual difficulties deserve a medical label and treatment.

    He believes that "drug marketing is merging with medical science in a fascinating and frightening way" and he asks whether we need a fresh approach to defining disease.

    He quotes a company employee saying that her company was interested in "expediting the development of a disease" and he reveals how companies are funding surveys that portray sexual problems as widespread and creating tools to assess women for "hypoactive sexual desire disorder."

    Many of the researchers involved in these activities were drug company employees or had financial ties to the industry, writes Moynihan. Meanwhile, scientific studies conducted without industry funding were questioning whether a widespread disorder of low desire really existed.

    Industry is also taking a leading role in "educating" both professionals and the public about this controversial condition, he adds.

    For example, a Pfizer funded course designed for doctors across the United States claimed that up to 63% of women had sexual dysfunction and that testosterone and s[ildenafi]l (['V'1]agra) may be helpful, along with behavioural therapy. And he points out that German drug company Boehringer Ingelheim's "educational" activities "went into overdrive" as the planned 2010 launch of its desire drug, flibanserin, approached.

    Compare to restless leg syndrome.

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    • (Score: 4, Touché) by VLM on Friday June 05 2015, @01:03PM

      by VLM (445) on Friday June 05 2015, @01:03PM (#192492)

      Certainly, the first drug for female sex drive may not be the most effective. Just because the idea was underfunded for decades

      The irony of funding, or money, being the most effective "pharmaceutical" for increased female desire is humorous.